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 * How We HelpShow submenu
   * When do I need to do ADME & Drug-Drug Interaction studies?
   * How is my drug cleared?
   * What test systems are needed for my in-house DMPK studies?
   * What nonclinical ADME / DDI studies do I need for a successful IND / NDA?
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RECOGNIZED EXPERTS IN ADME / DMPK / DDI BY 98% OF TOP PHARMA & COUNTLESS OTHERS
FOR DRUG METABOLISM AND DRUG-DRUG INTERACTION EXPERTISE.

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1


SEKSIUI XENOTECH EXPANDS ACCESS TO MICROSOMAL PROTEIN BINDING SERVICE FOR DMPK
PROFILE DEVELOPMENT AND DDI ASSESSMENT OF NEW DRUGS

To help customers more easily investigate how much of their drug will be
available to bestow its intended therapeutic effect, SEKISUI XenoTech is now
offering…


WEBINAR: AN OVERVIEW OF NON CYP-MEDIATED METABOLISM PATHWAYS AND IN VITRO
EVALUATION STRATEGIES

Although cytochrome P450 (CYP)-mediated metabolism continues to be of major
importance for a large proportion of small molecule new drug candidates, various
methods in recent…


SEKISUI XENOTECH CELEBRATES 25TH ANNIVERSARY

In 2019, SEKISUI XenoTech celebrated its 25th birthday, and our Japan branch
turned 64! Read about our journey from a...

The greatest strength of XenoTech is reputation for quality. That is an easy
one. Attention to detail. Quality of reports. When it comes to DMPK...

Pharma Chief Development Officer

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Great reports that are ready for submission to the Agency!

Pharma Senior Vice President of R&D

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Every XenoTech employee I had contact with throughout these studies have been a
pleasure to work with. The entire process was seamless. I never had...

Regulatory Affairs for Small Pharma

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There is a lot of quality, skilled work that has gone into this data set.
Compared to organizations that have done this type of work...

ADME Consultant

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> Great reports that are ready for submission to the Agency!
> 
> Pharma Senior Vice President of R&D

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> Every XenoTech employee I had contact with throughout these studies have been
> a pleasure...
> 
> Regulatory Affairs for Small Pharma

Continue Reading

> There is a lot of quality, skilled work that has gone into this data...
> 
> ADME Consultant

Continue Reading


YOUR DRUG’S JOURNEY…


YOUR DRUG’S JOURNEY…

057 liver and stomach Created with Sketch.



THROUGH THE BODY


THROUGH THE PIPELINE


ADME


DMPK


DDI

Absorption, Distribution, Metabolism, and Excretion (ADME) properties of a
xenobiotic describe its disposition and inform overall fate following
administration. SEKISUI XenoTech serves 98% of top pharma and countless others
by providing high-quality contracted ADME studies and test systems to precede or
support clinical trials.

Drug Metabolism & Pharmacokinetics (DMPK) is a core discipline in drug discovery
and development investigating how a drug is broken down and cleared, considering
both ADME and DDI characteristics to evaluate and optimize properties of a new
drug compound. Our drug metabolism and pharmacokinetics testing and products
allows sponsors to understand properties of their compounds and to evaluate risk
early in drug development and testing.

Drug-Drug Interaction (DDI) studies allow a drug developer to investigate the
potential of a xenobiotic compound to interact with drug-metabolizing enzymes
and drug transporters to predict the impact on the pharmacokinetics of the
compound or coadministered drugs. Drug metabolism and drug transporter studies
provide critical information in evaluating potential for drug-drug interactions
and associated risks in preclinical drug development.


IN
SILICO


IN
VITRO


IN
VIVO

In Silico Modeling uses mathematical models to evaluate in vitro data in a way
that provides meaningful risk prediction for drug metabolism and drug
interaction issues later in development or clinical trials.

In Vitro Studies & Test Systems allow drug developers to use cell-based assays
to determine ADME/PK characteristics and DDI potential of their drug compound.

Our In Vivo ADME / PK Studies use radiolabeled drug compound administered to
laboratory animals to investigate an investigational compound’s pharmacokinetic
propertiesinclusing drug metabolism and DDI risk.

FDA
Previous
NIH Leadership 2012
We need better drugs. We need to do better. We need to go faster and be more
successful
View Full Report
FDA Commissioner 2017
We need to make sure we’re taking steps to foster innovation and regulating
areas of promising new technology in ways that don’t raise the cost of drug
development or reduce innovation.
Learn More
Next
SEKISUI XenoTech facilitates the development of safer drugs with fewer failures
and lower costs through our state-of-the-art drug metabolism and DDI testing
programs to help drug developers understand as much as possible about their
drug's metabolism and pharmacokinetics to properly evaluate related drug safety
risks.
Over $2.8 billion is spent on the development of each launched drug

Only 1 in 10,000 potential drug compounds make it all the way through the
development pipeline

Over 80% of investigational new drugs fail because of unsatisfactory ADME/Tox



ACCESS ADME™ | SCIENTIFIC RESOURCES


ADME 101

Our new mini-webinar series exploring the what, why, and when of ADME, DMPK, and
DDI within your drug’s development


COMPARISON BETWEEN THE US FDA, EU EMA AND JAPAN PMDA IN VITRO DDI GUIDANCE
DOCUMENTS: ARE WE CLOSE TO HARMONIZATION?

Hear more about updates in regulatory expectations for drug metabolism and DDI
data between FDA, EMA, and PMDA


IN VITRO STUDY TIMING

Benefits & regulatory recommendations for conducting your drug metabolism &
drug-drug interaction studies earlier

View All
 * Drug Metabolism & DDI Expertise
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 * Contract Services
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